| CTRI Number |
CTRI/2024/11/077320 [Registered on: 25/11/2024] Trial Registered Prospectively |
| Last Modified On: |
05/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluating Sinarest Plus Suspension for Children with Common Cold: Safety and Efficacy Study |
|
Scientific Title of Study
|
A multicentric, non-randomized, open-label, non-comparative, active post-marketing surveillance study to evaluate the safety and efficacy of Sinarest Plus Suspension in children with common cold. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 088-20 version 1.0, dated 20-January-2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mayuresh Kiran |
| Designation |
Vice President Medical Services and Pharmacovigilance |
| Affiliation |
Centaur Pharmaceuticals Pvt Ltd |
| Address |
Centaur House, Near Grand Hyatt, Vakola ,Santacruz – East,
Mumbai – 400 055, India.
Mumbai
MAHARASHTRA
400055
India |
| Phone |
02267609156 |
| Fax |
|
| Email |
drmayuresh@centaurlab.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Pramita Waghambare |
| Designation |
Executive Pharmacovigilance and Biomedical Reasearch |
| Affiliation |
Centaur Pharmaceuticals Pvt Ltd |
| Address |
Centaur House, Near Grand Hyatt, Vakola ,Santacruz – East,
Mumbai – 400 055, India.
Mumbai
MAHARASHTRA
400055
India |
| Phone |
02267609341 |
| Fax |
|
| Email |
pramita@centaurlab.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Aakansha Singh |
| Designation |
Officer Medical Services |
| Affiliation |
Centaur Pharmaceuticals Pvt Ltd |
| Address |
Centaur House, Near Grand Hyatt, Vakola ,Santacruz – East,
Mumbai – 400 055, India.
Mumbai
MAHARASHTRA
400055
India |
| Phone |
02267609341 |
| Fax |
|
| Email |
med_user2@centaurlab.com |
|
|
Source of Monetary or Material Support
|
| Centaur Pharmaceuticals Pvt.Ltd., Mumbai, India |
|
|
Primary Sponsor
|
| Name |
Centaur Pharmaceuticals Pvt Ltd |
| Address |
Centaur House, Near Grand Hyatt, Vakola, Santacruz – East,
Mumbai – 400 055, India Mumbai (Suburban) MAHARASHTRA
400055 India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shivprakash Sosale |
Arunodaya Children Clinic |
Arunodaya Children Clinic,
No 20/1 Lakshmaiah Complex
T Dasarahalli
Bangalore 560057
Landmark: Near Soundarya Paradise Hotel.
Bangalore
KARNATAKA |
7204776479
shivaprakashsosale@gmail.com |
| Dr Sandip Bhople |
Kilbil Children’s Hospital |
Kilbil Children’s Hospital, 1st And 2nd Floor, Sarvoday Classic Building, Radhanagar, Khadakpada, Kalyan (West)
Mumbai
MAHARASHTRA |
9619968282
drsandip1903@gmail.com |
| Dr Amit Kumar |
Medicure clinic |
Maurya Path, Near Pillar No.15, Khajpura, Patna, Bihar-800014
Patna
BIHAR |
7544067738
coolmickeydoc@gmail.com |
| Dr Akshi Singh |
Upendra Medicare |
Upendra Medicare
S4/50-D-4-A, Mahaveer Mandir
Tajpur, Orderly Bazar, Varanasi, Uttar Pradesh, 221001.
Varanasi
UTTAR PRADESH |
9555112643
drakshisingh25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Pranav Diabetes Center Ethics Committee |
Approved |
| Shivnath Hospital Private Limited |
Approved |
| Sri Ram Hospital And Research Centre Pvt. Ltd. |
Approved |
| Suraksha Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00||Acute nasopharyngitis [common cold], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Sinarest Plus Suspension |
Sinarest Plus Suspension, FDC
of Paracetamol 250 mg,
Phenylephrine Hydrochloride 5
mg, Chlorpheniramine Maleate
2 mg, Sodium citrate 60 mg and
menthol 1 mg per 5 ml is
indicated for children with
common cold. 1) The patient’s guardians will be given Sinarest Plus Suspension Samples in the quantity of 2 x 50 ml and will be advised to give it to the patient in the dose as mentioned below for a study period of 5 days.
•For Ages 2 – 4 years – wt. 6 to16.5 Kg- dose 2.5 ml tid
• For Ages 4 – 9 Years- wt. 16.5 to 28.6 kg-dose 5 ml bid
• For Ages 9 – 12 Years- wt. 28.6 to 41.5 kg-dose 5 ml bid |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Patients of any age 2 to 12 years having body weight of 6 to 41.5 kg
Patients of either sex including male or female
Patients with confirmed diagnosis of common cold
Patients and guardians who are ready to adhere to the protocol
|
|
| ExclusionCriteria |
| Details |
Patients known to be hypersensitive to investigational product
Patients with severe Hepatic or Renal dysfunction |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in mean total symptom score
Percentage reduction in mean total symptom score at visit 2 and visit 3 as compared to visit 1 |
Day 1, Day 3 and Day 5 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="280"
Sample Size from India="280"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
02/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Sinarest Plus Suspension is a
fixed dose combination of Paracetamol 250 mg, Phenylephrine Hydrochloride 5 mg,
Chlorpheniramine Maleate 2 mg, Sodium citrate 60 mg and menthol 1 mg per 5 ml
which is indicated for the treatment of common cold in children. The rationale
behind this Active Post-Marketing Surveillance study is to document the
efficacy and safety of Sinarest Plus Suspension for the treatment of common
cold in children. Common cold of viral origin is a self-limiting disease which
usually takes up to 10 days to cure by itself. Allergic rhinitis is nasal
hypersensitivity symptoms persuaded by an immunologically mediated
(predominantly IgE dependent) inflammation as mucous membrane gets exposed to
allergens. The signs and symptoms of common cold overlaps with allergic
rhinitis and show similar symptoms. According to the guidelines of DPHHS
and Cochrane review combination of analgesic, antihistaminic and decongestant
medication can be used for the treatment of common cold. Taking this into
consideration we have initiated the Active Post-Marketing Surveillance study of
Sinarest Plus Suspension in children of common cold.
|